Anil Kumar Jain

Managing Director

The pharmaceutical CDMO market has witnessed a significant evolution in recent years, fueled by various factors. One such influential force has been the dynamic changes caused by the global pandemic, which prompted many expatriates to return to their home countries. As a result, an influx of large no of startup new companies has emerged over the period of time that is focused on developing new molecules and creating robust pipelines for unmet medical needs. However, these innovative companies often lack physical infrastructure including adequate skill, process, technology, research, and development & specific Manufacturing infrastructure to drive their ideas into reality.

This paradigm shift has opened doors for CDMOs like PI Health Sciences (PIHS) to become key players in bridging the gap and offering comprehensive solutions. With an expertise that dates back 75 years, PI Health Sciences (PIHS) has brought forward a complete ecosystem backed by its extensive knowledge of advanced Regulatory markets, and unfettered commitment to quality and sustainability. PI Industries is PIHS’ parent company that leverages a strong legacy of more than seven decades in offering complex chemistry and chemical engineering-driven process solutions, having worked with 25+ global innovators. It also brings over 50 years of working experience in the Japanese market which clearly depicts the competency of the PIHS today. “One of the unique differentiating factors of PIHS is its expertise in manufacturing complex chemicals, including those involving hazardous reactions, chlorination, fluorination, hydrogenation, and flow chemistry. With over seven decades of unparalleled experience, PIHS has developed specialized skills in these areas, making them proficient in manufacturing basic chemicals that serve as building blocks for both agrochemicals and pharmaceuticals”, highlights Anil Kumar Jain, Managing Director at PI Health Sciences.

All-Encompassing Pharmaceutical Value Chain

At the core of PIHS's offerings are three key verticals that cover the entire spectrum of the CDMO space. The first vertical, the Contract Research Organization (CRO), provides essential research services, including POC, Tox studies/ preclinical supplies, with a dedicated team of experts ensuring meticulous attention to detail. The second vertical seamlessly transitions from research to manufacturing as advanced molecules move to the CDMO Vertical. Here, PIHS leverages its manufacturing assets in Europe, which also holds the expertise in manufacturing of API (Active Pharmaceutical Ingredient) for Advance markets of the US, EU, Japan, and more. And the comprehensive understanding of the entire lifecycle of Drug substances, from conception to commercialization and postcommercialization management, empowers PIHS to deliver cost-effective solutions without compromising on operational excellence.

Narayan K. Seshadri, Chairperson

The third vertical focuses on Key Starting Materials (KSM) and API solutions, recognizing the critical need for a continuous supply of high-quality materials once a product is approved and launched in the market. PIHS's commitment to sustainable practices ensures that these materials are developed with minimal environmental impact, making them compliant with ESG (Environmental, Social, and Governance) standards. “We have a robust infrastructure in place with strict SOPs in place. Currently, we have three state-of-the-art research centers in the US and India. This is further backed by our two plants in India and Italy (GMP and Non-GMP compliant respectively). We have a perfect amalgamation of science, people, process, and technology which gives us the needed edge in the market today”, specifies Anil.

Mayank Singhal, Vice Chairperson & Managing Director

Recognizing the global nature of the pharmaceutical industry, PIHS remains well-versed in the regulatory requirements of various regions, including Europe, Japan, Korea, China, and India. The company's regulatory heads, with decades of experience in the field, ensure adherence to current guidelines, including ICH Q7 and Q10, further cementing PIHS's reputation for excellence. The company follows environmentally friendly processes that are carbonneutral, minimizing water and energy consumption. With state-of-the-art CSV-validated laboratories and advanced technologies, PIHS guarantees seamless operations and exceptional quality control.

Protecting Intellectual Property & Ensuring Quality

PIHS places utmost importance on safeguarding customer intellectual property (IP) rights, given its long-standing collaboration with innovators. Recognizing the criticality of IP security, PI has implemented stringent measures, including ISO 27001 certification for digital security, a feat achieved by only a handful of Indian companies. By ensuring a secure ecosystem, PIHS offers its clients transparency and real-time insights into the development process. Additionally, the company's commitment to quality is embedded throughout its operations. PIHS leverages advanced digital platform technologies like digitally controlled system, complete paperless operations, live tracking of project progress, scientific backing, and environmentally friendly processes to deliver a value-driven sustainable environment for its clients.

Reflecting on PIHS's journey, it is evident that the company has achieved significant milestones in a short period. With a rich legacy in the agrochemicals space and a track record of creating value for stakeholders, PIHS has quickly established itself as a leader in the industry. The recent acquisitions of the two companies across the US and Europe have propelled the company years ahead. And with an ambitious goal of multiplying its current turnover within next three years, PIHS is poised for exponential growth.

Going forward, PIHS envisions addressing the pharmaceutical industry's pressing need for costeffectiveness. The company aims to acquire businesses specializing in fermentation-based and enzymatic processes, expanding its capabilities and becoming a comprehensive provider in these areas.